Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019422
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2001-07-11
Brief Title:
Lobradimil and Carboplatin in Treating Children With Brain Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Intravenous Cereport RMP-7 and Carboplatin in Childhood Brain Tumors
Status:
COMPLETED
Status Verified Date:
2003-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Lobradimil may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of carboplatin and lobradimil in treating children with brain tumors that have not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of carboplatin and lobradimil in treating children with brain tumors that have not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with recurrent or refractory childhood brain tumors treated with lobradimil and carboplatin
Determine the time to progression in patients treated with this regimen
Assess the toxicity of this regimen in this patient population
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients are stratified according to histology high-grade glioma vs low-grade glioma vs brainstem or visual pathway glioma vs medulloblastomaprimitive neuroectodermal tumor vs ependymoma Brainstem glioma stratum closed to accrual as of 12212000 High-grade glioma stratum closed to accrual as of 01082002
Patients receive carboplatin IV over 15 minutes and lobradimil IV over 10 minutes on days 1 and 2 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity After completion of course 12 patients may receive additional courses at the discretion of the institutional investigator
Quality of life is assessed at baseline and then every 3 courses
Patients are followed every 3 months for 1 year or until evidence of disease progression or initiation of a new therapy
PROJECTED ACCRUAL A maximum of 146 patients will be accrued for this study within 2-4 years
Determine the objective response rate in patients with recurrent or refractory childhood brain tumors treated with lobradimil and carboplatin
Determine the time to progression in patients treated with this regimen
Assess the toxicity of this regimen in this patient population
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients are stratified according to histology high-grade glioma vs low-grade glioma vs brainstem or visual pathway glioma vs medulloblastomaprimitive neuroectodermal tumor vs ependymoma Brainstem glioma stratum closed to accrual as of 12212000 High-grade glioma stratum closed to accrual as of 01082002
Patients receive carboplatin IV over 15 minutes and lobradimil IV over 10 minutes on days 1 and 2 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity After completion of course 12 patients may receive additional courses at the discretion of the institutional investigator
Quality of life is assessed at baseline and then every 3 courses
Patients are followed every 3 months for 1 year or until evidence of disease progression or initiation of a new therapy
PROJECTED ACCRUAL A maximum of 146 patients will be accrued for this study within 2-4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COG-C09716 | None | None | None |
| NCI-98-C-0074H | None | None | None |
| CCG-09716 | None | None | None |
| ALK-01-041 | None | None | None |
| NCI-T98-0011 | None | None | None |